Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer

NCT00002537 | Completed Phase 1

• 4 other identifiers: NCI-2012-02487NYU-9301NCI-T93-0015DCDR0000078480
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I trial to study the effectiveness of radiation therapy plus topotecan in treating patients who have non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and radiation therapy may kill more tumor cells.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Study Arms (1)

Arm I

EXPERIMENTAL

Beginning on day 1, patients receive topotecan IV continuously for 3-6 weeks and thoracic radiotherapy 5 days a week for 2, 3, or 6 weeks. Cohorts of 4-6 patients receive escalating doses of topotecan and thoracic radiotherapy until the maximum tolerated dose (MTD) of each therapy is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Six additional patients are treated at the MTD. Patients who fail to achieve complete remission (CR) and continue to have measurable disease at 4-6 weeks after completion of radiotherapy receive topotecan IV continuously on days 1-21 at 1 dose level preceding the MTD as determined by the ongoing Protocol NYU-9123. Treatment continues every 4 weeks in the absence of unacceptable toxicity.

Drug: topotecan hydrochloride; Radiation: radiation therapy

Interventions

topotecan hydrochloride DRUG

Arm I

radiation therapy RADIATION

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven non-small cell lung cancer * Eligible for chest irradiation with 3,000 to 6,000 cGy (based upon standard radiotherapy indications) * Measurable or evaluable disease * Measurable disease defined as bidimensionally measurable lesion on physical exam or radiograph (CT or MRI acceptable) PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: 0-2 * Life expectancy: At least 12 weeks * WBC at least 4,000/mm3 * Platelet count at least 100,000/mm3 * Bilirubin no greater than 1.5 mg/dL * AST less than 3 times normal * Alkaline phosphatase less than 3 times normal * Creatinine no greater than 1.5 mg/dL * Not pregnant or nursing PRIOR CONCURRENT THERAPY: * No more than 1 prior chemotherapy regimen allowed * At least 4 weeks since prior chemotherapy and recovered * No prior radiotherapy * Recovered from toxic effects of any prior therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Topotecan; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Therapeutics

Study Officials

• Howard S. Hochster, MD

  NYU Langone Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 11, 2004
• Study Start: September 1, 1993
• Primary Completion: March 1, 2006
• Last Updated: February 11, 2013

Record last verified: 2006-05

Locations

US (1)